Genistein
Dietary SupplementAdministered orally once every 12 hours
NCT Number: NCT04105023
There is evidence that genistein present in soy can improve insulin resistance in rodents and humans with metabolic syndrome (MetS). However, it is not known if this improvement is associated with changes in the gut microbiota. In the present study, the investigators show that the consumption of genistein for 2 months could have an effect on insulin resistance in subjects with MetS. This effect will be accompanied by a modification of the gut microbiota taxonomy. As a consequence, there will be a reduction in metabolic endotoxemia accompanied by an increase in AMP-activated protein kinase (AMPK) phosphorylation and the expression of genes of fatty acid oxidation in skeletal muscle.
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
The investigators included 45 participants who met the following inclusion criteria: adults between 20 and 60 years of age with a diagnosis of MetS, HOMA index greater than 2.5, BMI ≥30 and ≤ 40 kg / m2 and who signed the consent letter. Patients who had any added pathology, pregnancy, smoking or consumed medications were excluded. Once the letter of informed consent was accepted, the patients were assigned to the respective treatment group. These individuals were advised to consume the recommended diet for subjects with MetS according to the guidelines of the ATPIII. Participants were randomly distributed to consume a) placebo treatment or b) genistein capsules (50 mg/day). The participants were followed for 2 months. In the previsit, informed consent letters were given, and blood samples were taken to evaluate glucose concentration, lipid profile, lipopolysaccharide and serum insulin. Also determined blood pressure, body weight, height, body composition and gut microbiota. The presence of insulin resistance was determined by means of the HOMA-IR index and by an oral glucose tolerance test. After 2 months, the same variables were assessed, and an expert surgeon in the operating room performed a vastus lateralis muscle biopsy, then RNA extraction and gene expression microarray assay was performed
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally once every 12 hours
Administered orally once every 12 hours
Time frame: Baseline to 2 month
Measurement of gut microbiota by sequencing using the Illumina platform
Time frame: Baseline to 2 month
serum glucose (mg/dL)
Time frame: Baseline to 2 month
serum insulin (µUI/ml)
Time frame: Baseline to 2 month
serum triglycerides (mg/dL)
Time frame: Baseline to 2 month
serum total cholesterol (mg/dL)
Time frame: Baseline to 2 month
serum LDL cholesterol (mg/dL)
Time frame: Baseline to 2 month
serum HDL cholesterol (mg/dL)
Time frame: Baseline to 2 month
plasma lipopolysaccharide (LPS) (ng/mL)
Time frame: Baseline to 2 month
body weight (kg)
Time frame: Baseline to 2 month
blood pressure (mmHg)
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Other
Genistein Stimulates Insulin Sensitivity Through Gut Microbiota Reshaping and Skeletal Muscle AMPK Activation in Obese Subjects
Acronym: GENISTEIN
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